Design Changes

Design changes for a medical device is very common due to many reasons such as a replacement with a better and cheaper components or to comply with a new regulatory guideline. 

 

For example to comply with Restriction of Hazardous Substances (RoHS) also known as Directive 2002/95/EC and it was originated from European Union to restricts the use of six hazardous materials found in electrical and electronic products. All applicable medical device in the after July 1, 2006 must pass RoHS compliance. 

 

Therefore, medical device companies may have many design changes to comply with RoHS in order to market the product in the EU. This may be a major design change involving many components depending on the complexity of the medical device in question.

 

In general, there are two types of design changes, the first is during design process of the device and the second is changes after the device had been released. 

 

During the design process, for example, before design output documents are transferred to production, design changes are controlled internally within the Design Engineering group and other per company protocol. 

 

In this phase the project manager of the developmental product has the authority to approve all changes. The manner in which the request for change, its review, and change authorization are documented depends on the nature of the change and how early or late in the design cycle the change is done. 

 

Typically, these changes are documented as notes on design documents such as:

• Drawings
• Specifications,
• Calculations,
• Minutes of design review meetings

However, after the design is released to regulators for pre-market approval, is undergoing clinical trials, or is released to production, it will be a lot more involvement of many departments like regulatory affairs, engineering, marketing and validation group etc. 

 

The changed device many need to have to be partially validated again or the engineering group many need to perform risk analysis and update the risk managemet file. 

 

The sponsor should also comply with Engineering Change Request, Control of Documents and regulatory affairs protocol. For example, after the product is deemed RoHS, the label should have a sticker of RoHS added to that effect.

Reference	Criteria
21 CFR 820.30(i)	Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.

Device Master Record- Part II

This is the second section of the blog on Device Master Record (DMR). This blog talks about format of DMR index and the review, approval and change control of documents.

            1) Format of the DMR Index

DMR is maintained on the company computer network in a Microsoft Word table, Excel or equivalent format. The model of the DMR table should have a formal index form as well entitled Device Master Record Index.

Individual documents referenced in the DMR Index are identified by:

• Document Number,
• Title (or description),
• Category and document type (drawing, bill of materials, procedure,
  work instruction, etc.)
• issuing authority like department; engineering, regulatory affirs etc.

         The effective date, revision level, and distribution of a document included in the
         DMR, the DMR Index should be cross-referenced with the appropriate Document  
         Control Master List, where the document status information is maintained to avoid
         confusion.

          2) Review, approval and changes

The initial DMR Index, and any subsequent addition or deletion of documents form the index, are to be reviewed and approved by the individual responsible for Quality Assurance plus other departments. 

The review and approval of the DMR Index is to ensure the completeness and relevance of the DMR index, rather than for the correctness of the individual DMR documents. The individual documents in the index should have been independently reviewed and approved by their issuing authority, in accordance with the procedure entitled in “Control of Documents”.

DMR review, approval, change control, distribution control, retention of obsolete copies, and other document control requirements are the same as apply generally to controlled documents, as specified in Procedure “Control of Documents”.

This DMR index must be treated with seriously and any update must be performed expeditiously to reflex other related changes. For example, if there is a change in the bill of material and it is not updated quickly in the index, the purchasing department may buy the wrong components.

Reference	Criteria
21 CFR 820.181	Has the company maintained device master records (DMR’s)?
21 CFR 820.181	Has the company ensured that each DMR is prepared and approved in accordance with Document Control requirements?
21 CFR 820.181 (a)	Does the DMR for each type of device include, or refer to the location of, device specifications including appropriate drawings, component specifications, and software specifications?
21 CFR 820.181 (b)	Does the DMR for each type of device include, or refer to the location of, production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications?
21 CFR 820.181 (c)	Does the DMR for each type of device include, or refer to the location of, quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used?
21 CFR 820.181 (d)	Does the DMR for each type of device include, or refer to the location of, packaging and labeling specifications, including methods and processes used?
21 CFR 820.181 (e)	Does the DMR for each type of device include, or refer to the location of, device specifications including appropriate drawings, component specifications, and software specifications, and installation, maintenance and servicing procedures and methods?

Disclaimer: Although the author had exhaustively researched all sources to ensure the accuracy and completeness of the information contained in this blog, but no warranty and fitness is implied. I assumed no responsibility and implied warranty of any kind for errors, inaccuracies, omission, or any inconsistency herein. No liability is assumed for incidental or consequential damages in connection with the use of the information contained herein. Readers should always use their own judgment and review all related regulatory guidelines. Guidelines can change over time.